Adhesive Small Bowel ObstructionPhase 3NCT06182319
Optimizing Treatment of Adhesive Small Bowel Obstruction
A Phase 3 study testing Gastrografin, Saline and SBO Treatment Without NG Tubes in people with Adhesive Small Bowel Obstruction, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Small bowel obstruction (SBO) is one of the most common causes of serious gastrointestinal disease in the US. Adhesion-related SBO (aSBO) is usually treated by the placement of a nasogastric tube (NGT) to decompress the stomach, administration of intravenous (IV) fluids and observation by a surgical team. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Small Bowel Obstruction
- What is being tested?
- Gastrografin, Saline and SBO Treatment Without NG Tubes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 15 Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years of age.
- Documentation of aSBO as evidenced by one or more clinical features meeting the following criteria: Nausea, emesis, abdominal pain, distended abdomen CT evidence of aSBO
Who cannot join
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
- Unstable angina or recent myocardial infarction (MI)/stroke within 6 months
- Nonadhesive SBO
- Paralytic Ileus
- Incarcerated hernia
- Fecal impaction
- Intra-abdominal malignancy Early aSBO within 4 weeks of a prior abdominal operation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Edward H Livingston, MD contact
United States1 site, 1 recruiting
- Recruiting
University of California, Los Angeles, David Geffen School of Medicine
Los Angeles, California, 90024
310-825-2631
About this study
Official title: The Use of Nasogastric Tubes And Water-Soluble Contrast In The Management Of Small Bowel Obstruction: A Feasibility Study
Small bowel obstruction (SBO) is one of the most common causes of serious gastrointestinal disease in the US. Adhesion-related SBO (aSBO) is usually treated by the placement of a nasogastric tube (NGT) to decompress the stomach, administration of intravenous (IV) fluids and observation by a surgical team.
The purpose of this feasibility study is to determine the potential for implementation of treatment protocols for aSBO and determine the feasibility of randomizing patients with aSBO to receive or not receive NGTs or water-soluble contrast (WSC). The investigators will also determine the ability to measure HRQOL as a main outcome for the treatment of aSBO. The studies outlined in this research program intend to address gaps in knowledge about how to determine who benefits from NGT placement, who can be managed without them, how to objectively determine when a bowel obstruction has resolved, how to reintroduce feeding to patients with aSBO, what criteria should be used for hospital discharge and what role cathartics such as WSC contrast have in the management of aSBO.
This feasibility study will enroll a limited number of patients (n=40) who will be followed for up to 30 days.
- Conditions
- Adhesive Small Bowel Obstruction
- Being tested
- Gastrografin, Saline, SBO Treatment Without NG Tubes
- Keywords
- nasogastric tube (NGT), water-soluble contrast (WSC), Adhesion-related SBO (aSBO), Small bowel obstruction (SBO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastrografinDrug
Administration of WSC (Gastrografin) 2 hours after placement of NGT.
SalineDrug
Administration of Saline 2 hours after placement of NGT.
SBO Treatment Without NG TubesProcedure or surgery
Patients who decline to have NG tubes placed will be enrolled and followed with the same outcomes protocol as the other patients in the trial
| Study group | Role | What they receive |
|---|---|---|
| SBO treated without NG tube | Experimental | Patients who decline NG intubation will be enrolled in the trial, followed prospectively and have the same outcome measures as are acquired in the other study arms. Receives: Procedure: SBO Treatment Without NG Tubes |
| SBO treated with NG tube and Water-Soluble Contrast (WSC) | Experimental | Patients who select NG tube treatment will be randomized into experimental and control groups. The experimental groups will have 100 cc of WSC administered in the NG tube within 2 hours of NG tube placement. Receives: Drug: Gastrografin |
| SBO Treated with NG tube and Placebo | Placebo comparator | The control group will have 100cc of saline administered via the NG tube within 2 hours of NG tube placement. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcomes Measurement Information System (PROMIS®)-29
Quality of life will be assessed using the PROMIS-29 HRQOL instrument. The survey uses multiple response formats. A total score provides an index of HRQOL, with higher scores on a scale of 0-100 reflecting better HRQOL.
Measured: The measure will be obtained at baseline when a diagnosis of aSBO is made, at hospital day 1, the day after an NGT is removed, the day a patient is discharged from the hospital and at 30 days after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Jan 2024
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Small Bowel ObstructionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be allocated into 3 groups: One treated without NG tubes. The other 2 groups will have an NG tube and be randomized into treatment with water-soluble contrast or saline.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Harry Livingston, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182319
- Sponsor's protocol ID
- 23-001055
- Status last verified
- May 2024
- First submitted
- 30 Nov 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Nasogastric Tubes And Water-Soluble Contrast In The Management Of Small Bowel Obstruction: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06182319
- Acronym / sponsor ID
- 23-001055
- Conditions
- Adhesive Small Bowel Obstruction
- Keywords
- nasogastric tube (NGT), water-soluble contrast (WSC), Adhesion-related SBO (aSBO), Small bowel obstruction (SBO)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Small bowel obstruction (SBO) is one of the most common causes of serious gastrointestinal disease in the US. Adhesion-related SBO (aSBO) is usually treated by the placement of a nasogastric tube (NGT) to decompress the stomach, administration of intravenous (IV) fluids and observation by a surgical team.
The purpose of this feasibility study is to determine the potential for implementation of treatment protocols for aSBO and determine the feasibility of randomizing patients with aSBO to receive or not receive NGTs or water-soluble contrast (WSC). The investigators will also determine the ability to measure HRQOL as a main outcome for the treatment of aSBO. The studies outlined in this research program intend to address gaps in knowledge about how to determine who benefits from NGT placement, who can be managed without them, how to objectively determine when a bowel obstruction has resolved, how to reintroduce feeding to patients with aSBO, what criteria should be used for hospital discharge and what role cathartics such as WSC contrast have in the management of aSBO.
This feasibility study will enroll a limited number of patients (n=40) who will be followed for up to 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will be allocated into 3 groups: One treated without NG tubes. The other 2 groups will have an NG tube and be randomized into treatment with water-soluble contrast or saline.
| Arm | Type | Receives |
|---|---|---|
| SBO treated without NG tube | Experimental | Procedure: SBO Treatment Without NG TubesPatients who decline NG intubation will be enrolled in the trial, followed prospectively and have the same outcome measures as are acquired in the other study arms. |
| SBO treated with NG tube and Water-Soluble Contrast (WSC) | Experimental | Drug: GastrografinPatients who select NG tube treatment will be randomized into experimental and control groups. The experimental groups will have 100 cc of WSC administered in the NG tube within 2 hours of NG tube placement. |
| SBO Treated with NG tube and Placebo | Placebo comparator | Drug: SalineThe control group will have 100cc of saline administered via the NG tube within 2 hours of NG tube placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female ≥18 years of age.
- Documentation of aSBO as evidenced by one or more clinical features meeting the following criteria: Nausea, emesis, abdominal pain, distended abdomen CT evidence of aSBO
Key exclusion criteria (8 listed)
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
- Unstable angina or recent myocardial infarction (MI)/stroke within 6 months
- Nonadhesive SBO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GastrografinAdministration of WSC (Gastrografin) 2 hours after placement of NGT. | Drug | SBO treated with NG tube and Water-Soluble Contrast (WSC) |
| SalineAdministration of Saline 2 hours after placement of NGT. | Drug | SBO Treated with NG tube and Placebo |
| SBO Treatment Without NG TubesPatients who decline to have NG tubes placed will be enrolled and followed with the same outcomes protocol as the other patients in the trial | Procedure or surgery | SBO treated without NG tube |
Primary outcome
Patient-Reported Outcomes Measurement Information System (PROMIS®)-29
Time frame: The measure will be obtained at baseline when a diagnosis of aSBO is made, at hospital day 1, the day after an NGT is removed, the day a patient is discharged from the hospital and at 30 days after discharge.
Quality of life will be assessed using the PROMIS-29 HRQOL instrument. The survey uses multiple response formats. A total score provides an index of HRQOL, with higher scores on a scale of 0-100 reflecting better HRQOL.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- The Effect of Hyperosmolar Water-Soluble Contrast for the Management of Adhesive Small Bowel Obstruction: A Systematic Review and Meta-AnalysisLink provided by the sponsor.
- Management of small bowel obstruction and systematic review of treatment without nasogastric tube decompressionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edward H Livingston, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gastrografin, Saline and SBO Treatment Without NG Tubes in people with Adhesive Small Bowel Obstruction, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven Stokes (310-206-7436, sstokes@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System (PROMIS®)-29 (time frame: The measure will be obtained at baseline when a diagnosis of aSBO is made, at hospital day 1, the day after an NGT is removed, the day a patient is discharged from the hospital and at 30 days after discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.